BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 2223068 · Received August 21, 2011

    Report

    Report Number
    MW5021846
    Event Type
    Malfunction
    Date Received
    August 21, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 21, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN A LUER LOCK SYRINGE IS ATTACHED TO THE FEMALE END OF THE MICROBORE TUBING THE PALE YELLOW HUB ON THE TUBING IS CRACKING SLIGHTLY. THE CRACK HAS NOT BEEN NOTICED UNTIL THE SLOW LEAK IS NOTED. PRESENTS AN INFECTION RISK AND IT IS VERY DIFFICULT TO KNOW HOW MUCH MEDICATION THE PT ACTUALLY RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYRINGE SET: MICROBORE TUBING WITH A PRESSURE SENSING FPA CARDINAL HEALTH 840032398 NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1